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Insulin Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3013858Model 2×50 tests/kitRef 3008773Model 1×100 tests/kitRef 3013877Model 1×50 tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Insulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Insulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
2×50 tests/kit EUDAMED
3013858 EUDAMED
1×100 tests/kit EUDAMED
3008773 EUDAMED
1×50 tests/kit EUDAMED
3013877 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202224003 EUDAMED
06925794511928 EUDAMED
06925794520357 EUDAMED
Basic UDI-DI
B-06942202224003 EUDAMED
B-06925794511928 EUDAMED
B-06925794520357 EUDAMED
EMDN Code
W0102060103 INSULIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Insulin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 23d30b93-1bf7-48fb-82da-95e13fdaf794 61 fields · synced Jul 10, 2026
  • EUDAMED 6137721c-3798-4b35-ad31-d2e77afe38b9 61 fields · synced May 17, 2026
  • EUDAMED 4bbdf5dd-facf-450e-83bd-e7adbfd51460 61 fields · synced May 19, 2026